C. B. HEALTHCARE, THROUGH ITS AUTHORIZED SIGNATORY SHRI ASHISH KUMAR v. UNION OF INDIA THROUGH DRUG INSPECTOR PUSHPRAJ KUMAR SINGH
Quashing of Prosecution under Drugs & Cosmetics Act due to Inordinate Testing Delay and Deprivation of the Accused's Right to Re-analysis after Drug Expiry.
Court: Bombay High Court
Citation: 2026:BHC-AS:14013
Decision Date: 24-03-2026
List of Laws
Drugs & Cosmetics Act, 1940; Drugs Rules, 1945; Code of Criminal Procedure, 1973; Constitution of India; Principle of Vicarious Liability; Right to Retesting and Re-analysis
- Facts: The Petitioner No. 1 is a pharmaceutical partnership firm, and Petitioner Nos. 2 to 5 are its partners. In November 2016, a Drugs Inspector drew samples of "FEXINOL-12" tablets manufactured by the Petitioners from a hospital store in Silvassa. The sample was sent to the Government Analyst, who issued a report in July 2017—seven months later—stating the drug was "not of standard quality". Although the manufacturer was identified, the Inspector sent the statutory notice and sample portion to the distributor, merely marking a copy to the Petitioner. In September 2021, over three years after the drug's expiry (August 2018), the Respondent filed a criminal complaint under Section 27(d) of the Drugs & Cosmetics Act, 1940.
- Procedural Posture: The Petitioners approached the High Court of Judicature at Bombay by filing a Writ Petition under Article 227 of the Constitution of India, seeking to quash the criminal prosecution and the order of issuance of process passed by the Special Judge, Dadra and Nagar Haveli.
- Issue: Whether the prosecution is sustainable given the inordinate delay in testing the sample, the failure to provide a sample portion directly to the manufacturer, and the filing of the complaint after the drug's shelf life had expired, thereby depriving the accused of the right to retesting.
- Holding: No, the prosecution is not sustainable. The Court quashed the proceedings, holding that the cumulative effect of procedural infractions and the loss of the right to re-analysis amounted to an abuse of the process of law.
- Reasoning: The Court reasoned that Rule 45 of the Drugs Rules, 1945, is peremptory, requiring a report within sixty days; an unexplained seven-month delay renders the analysis suspect as drug properties may deteriorate. Furthermore, under Section 23(4) and Section 25 of the Act, the accused has a valuable right to have the sample re-tested by the Central Drugs Laboratory. By lodging the complaint in 2021, long after the drug expired in 2018, the Respondent made re-analysis impossible. Relying on Supreme Court precedents like "Laborate Pharmaceuticals", the Court held that depriving the accused of this statutory right to contest the Analyst's report through re-analysis makes the prosecution "lame". Additionally, the Court noted that the Special Judge erred in taking cognizance directly without the case being committed by a Magistrate, as required by Section 193 of the CrPC.
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